Senior Validation Engineer (Pharmaceutical)

TL;DR

Senior Validation Engineer (Pharmaceutical): Evaluating and approving validation plans, protocols, reports, and quality-system documentation for a penicillin manufacturing facility with an accent on GMP compliance, equipment and process qualification, and regulatory readiness. Focus on troubleshooting validation issues, analyzing process data, supporting product transfers and audits, and coordinating complex quality investigations.

Location: Onsite in Rochester, Michigan, United States. Permanent U.S. work authorization is required; visa sponsorship is not available. Relocation assistance may be available based on business needs and eligibility.

Salary: $82,700–$137,900 annual base salary, plus eligibility for a 10% bonus target.

Company

A global pharmaceutical company focused on developing and manufacturing medicines and maintaining rigorous product quality standards.

What you will do

• Evaluate, review, and approve validation master plans, protocols, reports, and technical documentation.
• Troubleshoot equipment and process-validation issues and provide recommendations for resolution.
• Perform statistical analysis of test results, process anomalies, and quality-investigation data.
• Manage quality systems including change control, quality agreements, documentation, and investigations.
• Maintain the site Validation Master Plan, support regulatory audits, and represent validation engineering on site and network teams.
• Support product transfers, new product development, cleaning validation, deviation investigations, and production validation scheduling.

Requirements

• High school diploma with 8+ years of relevant experience, associate’s degree with 6+ years, BA/BS with 2+ years, or MBA/MS with relevant experience.
• Proven expertise in Good Manufacturing Practices and strong knowledge of quality systems and processes.
• Familiarity with document management, enterprise resource planning, and quality-tracking systems.
• Strong written and verbal communication skills and the ability to work independently and collaboratively.
• Must be authorized to work permanently in the United States; U.S. visa sponsorship is not available now or in the future.
• Must not be allergic to penicillin, must be able to aseptically gown, and must be able to lift 25–30 pounds.

Nice to have

• Validation or qualification experience with pharmaceutical processes, equipment, utilities, facilities, or computer systems.
• Experience with sterile products, medical devices, regulatory audits, and compliance activities.
• Strong analytical, problem-solving, organizational, and time-management skills.
• Experience mentoring colleagues and using generative AI tools such as ChatGPT or Microsoft Copilot responsibly.

Culture & Benefits

• Quality-focused, science-driven, risk-based compliance culture.
• Comprehensive medical, prescription, dental, and vision coverage.
• 401(k) matching and additional retirement savings contributions.
• Paid vacation, holidays, personal days, caregiver/parental leave, and medical leave.
• Non-standard hours, including weekend, second-shift, night-shift, or on-call support, may be required for product release.
• Minimal travel for training and seminars.